| Autor: |
Patti, Francesco, Zimatore, Giovanni Bosco, Brescia Morra, Vincenzo, Aguglia, Umberto, Bossio, Roberto Bruno, Marziolo, Roberto, Valentino, Paola, Chisari, Clara Grazia, Capacchione, Antonio, Zappia, Mario |
| Předmět: |
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| Zdroj: |
Journal of Neurology; Jun2020, Vol. 267 Issue 6, p1812-1823, 12p, 1 Illustration, 1 Diagram, 3 Charts, 1 Graph |
| Abstrakt: |
Background: Subcutaneous recombinant interferon-beta 1a (IFN-β1a SC) is indicated for treatment of relapsing multiple sclerosis (RMS); however, it is associated with development of flu-like syndrome (FLS) in 75% of patients. No recommendations are available on whether evening or morning administration could induce better or worse FLS. Objective: Primary objective was to investigate whether morning administration of IFN-β1a 44 µg (Rebif) would affect the severity of FLS versus evening administration, in patients with RMS. Secondary objectives were to investigate whether timing of administration could lead to a better quality of life. Methods: Multicenter, open-label, 12-week, randomized, controlled, parallel-group, phase 4 study. Results: Of 217 patients screened at 29 Italian sites, 200 were included in the study. Among these, 104 patients were randomized to IFN-β1a SC administration in the morning and 96 in the evening. Morning administration resulted in higher FLS scores, as measured by the Multiple Sclerosis Treatment Concern Questionnaire, at week 4 (p = 0.0083) and week 8 (p = 0.0079); however, the difference was no longer significant at the end of 12 weeks. Conclusion: IFN-β1a evening injections in the first 8 weeks of treatment led to an improvement in FLS; when continuing therapy, time of administration could be decided according to patient's lifestyle and preference. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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